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Randomised trial comparing biweekly oxaliplatin plus oral capecitabine versus oxaliplatin plus i.v. bolus fluorouracil/leucovorin in metastatic colorectal cancer patients: results of the Southern Italy Cooperative Oncology study 0401

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Abstract

Purpose

Oxaliplatin combined with either fluorouracil/leucovorin (OXAFAFU) or capecitabine (OXXEL) has a demonstrated activity in metastatic colorectal cancer patients. We aimed at comparing these two regimens in terms of response rate (RR), safety, progression-free survival (PFS), and quality of life (QoL) of patients.

Methods

A total of 322 patients with metastatic colorectal cancer were randomized to receive biweekly: oxaliplatin 100 mg/m2 i.v. on day 1, capecitabine 1,000 mg/m2 orally twice daily from day 1 to day 11 (OXXEL); or oxaliplatin 85 mg/m2 i.v. on day 1; 6S-leucovorin 250 mg/m2 i.v. and fluorouracil 850 mg/m2 i.v. on day 2 (OXAFAFU).

Results

Eleven complete and 42 partial responses were registered with OXXEL (RR = 34%); six complete and 48 partial responses were obtained with OXAFAFU (RR = 33%) (P = 0.999). Severe adverse events were less frequent (32 vs. 43%) with OXXEL, which also reduced the occurrence of severe neutropenia (10 vs. 27%) and febrile neutropenia (6 vs. 13%), but produced more gastric side effects (8 vs. 3%) and diarrhea (13 vs. 8%). QoL did not differ across the two arms. Median PFS was 6.6 months in the OXXEL, and 6.5 months in the OXAFAFU arm (HR = 1.12, P = 0.354). Median overall survival was 16.0 and 17.1 months (HR = 1.01, P = 0.883).

Conclusions

OXXEL and OXAFAFU regimens were equally active in metastatic colorectal cancer. The choice should be based on patient preference and on pharmacoeconomic evaluations.

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Acknowledgments

The following investigators of the Southern Italy Cooperative Oncology Group are acknowledged as contributors to this trial: Rossana Casaretti MD, Claudia Sandomenico MD, Department of Medical Oncology, National Tumour Institute, Naples; Silvana Leo MD, Medical Oncology, City Hospital, Lecce; Salvatore Tafuto MD, Medical Oncology, City Hospital, Pozzuoli; Ettore Greco MD, Medical Oncology, City Hospital, Lametia Terme; Mario Roselli PhD, Chair of Medical Oncology, Tor Vergata University Medical School, Rome; Valerio Milia MD, Medical Oncology, City Hospital, Macomer; Antonio Gambardella PhD, Chair of Geriatrics, Second University Medical School, Naples; Sergio Mancarella MD, Medical Oncology, City Hospital, Galatina; Giancarlo Di Pinto MD, Medical Oncology, City Hospital, Castrovillari; Lucio De Luca MD, Medical Oncology, Pellegrini Hospital, Naples; Giacomo Vessia MD, Medical Oncology, City Hospital, Altamura, Italy. This work was partially supported by Italian Ministry of Health (FSN 2004). We thank Luca Franco and Marina Licenziato for their invaluable contribution in the data management.

Conflict of interest statement

None to declare.

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Authors and Affiliations

  1. Department of Medical Oncology, National Tumour Institute, Via M. Semmola, 80100, Naples, Italy

    Pasquale Comella

  2. Chair of Medical Oncology, University Medical School, Strada Statale 554, 09100, Cagliari, Italy

    Bruno Massidda

  3. Depatment of Medical Oncology, City Hospital, Via Promintesta, 87027, Paola, Italy

    Gianfranco Filippelli

  4. Chair of Medical Oncology, University Medical School, Via S. Pietro 8, 07100, Sassari, Italy

    Antonio Farris

  5. Depatment of Medical Oncology, City Hospital, via Nazionale Nord 99, 65017, Penne, Italy

    Donato Natale

  6. Depatment of Medical Oncology, Villa Betania Hospital, Via Argine, 80100, Naples, Italy

    Giuseppe Barberis

  7. Depatment of Medical Oncology, San Gennaro Hospital, Via San Gennaro dei Poveri 5, 80100, Naples, Italy

    Luigi Maiorino

  8. Chair of Medical Oncology, University Medical School, Via del Vespro 127, 90100, Palermo, Italy

    Sergio Palmeri

  9. Depatment of Medical Oncology, City Hospital, Via Bovio, 70031, Canosa, Italy

    Michele Cannone

  10. Depatment of Medical Oncology, City Hospital, Via Zara, 89048, Siderno, Italy

    Giovanni Condemi

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  1. Pasquale Comella
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on behalf of the Southern Italy Cooperative Oncology Group

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Correspondence to Pasquale Comella.

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Comella, P., Massidda, B., Filippelli, G. et al. Randomised trial comparing biweekly oxaliplatin plus oral capecitabine versus oxaliplatin plus i.v. bolus fluorouracil/leucovorin in metastatic colorectal cancer patients: results of the Southern Italy Cooperative Oncology study 0401. J Cancer Res Clin Oncol 135, 217–226 (2009). https://doi.org/10.1007/s00432-008-0454-7

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